UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057944 |
|---|---|
| Receipt number | R000065937 |
| Scientific Title | Exploratory study of the effects of test food intake on lipid-related indices |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/06/12 11:34:18 |
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Basic information
Public title
Exploratory study of the effects of test food intake on lipid-related indices
Acronym
Exploratory study of the effects of test food intake on lipid-related indices
Scientific Title
Exploratory study of the effects of test food intake on lipid-related indices
Scientific Title:Acronym
Exploratory study of the effects of test food intake on lipid-related indices
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the effects of 12 consecutive weeks of consumption of the test food on lipid-related indices and to evaluate its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Exploratory endpoints
1) Lipid-related indicators(1)
2) Additional Exploratory Indicators(1)
3) Physical examination(1)
4) Clinical examination(1)
5) Eating Tendency Survey(1)
* Safety endpoints
1) Doctor's questions(1)
2) Side effects/ Adverse events(2)
3) Subject's diary(3)
(1):Week 0, Week 6, Week 12
(2):Week 6, Week 12
(3):From the first day of ingestion of a test material to the last day of the test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 packet in a day; 12 weeks).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals with LDL cholesterol in the borderline (120 mg/dL to 139 mg/dL) or mild range (140 to 159 mg/dL).
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
4) Individuals who can come to the designated venue for this study and be inspected.
Key exclusion criteria
Individuals
1) with chronic diseases and individuals undergoing treatment for any disease
2) with a history or current medical history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3) with a history or current medical history of serious diseases of the liver, kidney, heart, lung, blood, digestive tract, etc.
4) with serious anemia.
5) who have a habit of taking or applying medication for the purpose of disease treatment in the past month.
6) whose BMI is over 30 kg/m2.
7) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
8) who are currently, or have been within the past 3 months, habitually consuming or will consume during the study period foods, foods for specified health uses, foods with functional claims, health foods, supplements, etc. that contain a large amount of ingredients similar to those in the test foods.
9) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent.
10) who are a smoker.
11) who work in shifts, work at night, or otherwise have irregular lifestyles.
12) with possible changes of life style during the test period (e.g., work at night, travel for long periods of time, etc.).
13) who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study.
14) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
15) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period.
16) judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueno |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
049-242-8165
hiroshi-ueno@meg-snow.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065937
